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Health Canada's compliance verification program has determined that one lot the product (Lot Number E20A139R), does not meet the requirements of the Consumer Chemicals and Containers Regulations, 2001 (CCCR, 2001) in Canada. Specifically,…

Potential for a small open channel in the lift and peel aluminum seal resulting in a compromised sterile barrier, potential for a lack of sterility assurance. Recall start date: November 13, 2023

Stryker received one (1) complaint for a LITe Decompression Tube Snake Arm that did not fit on to the arm post shaft that mounts to the hospital bed. Subsequent investigation determined a portion of one lot of the LITe Decompression Tube Snake Arm was…

When processing specific patient plasma specimens with the Aptima® CMV Quant Assay, a ML2 error flag may occur, which will invalidate specimens within the assay run. Recall start date: November 20, 2023

During an evaluation of user implementation of the instructions for use related to the reprocessing of the LTF-S190-5 videoscope, Olympus observed deviations from the following reprocessing steps detailed in the respective reprocessing manual…

An internal screw could drop between the cover rib and the cell printed circuit board and cause a short circuit, posing a fire hazard. As of November 7, 2023, the company has received no reports of incidents in Canada, and no reports of injuries. In…

The recalled product does not meet the labelling requirements and the child-resistant packaging requirements of the Consumer Chemicals and Containers Regulations, 2001 under the Canada Consumer Product Safety Act. The lack of appropriate labelling and…

Upon insertion of a new (unused) Ligasure™ device, the Valleylab™ FT10 energy platform running software versions 4.0.1, 4.0.2 and 4.0.3 may erroneously indicate that the Ligasure™ device was used previously. When this occurs, the energy platform will…

Ambu has received information on two incidents where Ambu® aView™ 2 Advance caught fire when mounted on the vesa holder of the aCart™ compact, due to incorrect length screws used penetrating the lithium-ion battery of the device. Investigations have…

Medtronic recently identified that if the Synchromed II Pump switches into telemetry mode due to electromagnetic interference (EMI) from an MRI scan, while the pump is sounding an alarm, the pump will not resume drug delivery after leaving the MRI…

Health Canada has determined that the recalled blinds do not meet the Corded Window Coverings Regulations and pose a strangulation hazard. The product can create loops exceeding 44cm. Young children may pull looped cords around their neck…

Olympus is taking this recall action after investigating reported complaints about issues inflating, deflating and/or retrieving the devices, as well as reports of bursting and leaking. Olympus has received reported adverse events involving foreign body…

Baxter Corporation is issuing an urgent medical device recall for the Amia Automated Peritoneal Dialysis (APD) cycler set listed due to an increase in complaints related to failure alarms for wet cassette integrity test occurring on the Amia devices.…

Our recent interference testing has shown that the presence of lubricants in the vaginal specimen may interfere with the prom test result, which deviates from what is presented in the instructions for use. The defectiveness was discovered 2023-11-08.…

The affected products are being recalled from the marketplace due to various non-compliances related to caffeine content and labelling requirements.